Acne VulgarisNCT03707236
The Use of Teledermatology in the Treatment of Patients With Severe Acne on Isotretinoin
A study testing Teledermatology visits in people with Acne Vulgaris, run by Massachusetts General Hospital.
Trial summary
This is a non-blinded randomized controlled non-inferiority trial designed to assess the efficacy and role of teledermatology visits in the treatment of patients with severe acne starting isotretinoin. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Teledermatology visits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients must have a diagnosis of severe acne by a dermatologist with a plan of initiating treatment with isotretinoin
- Patients must first be enrolled in iPledge prior to eligibility
Who cannot join
- Patients who have baseline hepatic dysfunction or hypertriglyceridemia
- Patients with a history of depression, suicide attempts or suicidal ideation
- Patients without access to internet or a camera (including portable camera and/or smart phone) at home
- Patients who are pregnant - absolute contraindication
About this study
Official title: The Use of Teledermatology in the Treatment of Patients With Severe Acne on Isotretinoin: A Randomized-controlled Trial
This is a non-blinded randomized controlled non-inferiority trial designed to assess the efficacy and role of teledermatology visits in the treatment of patients with severe acne starting isotretinoin. Males and females 16 years or older will be randomized to either the control arm (monthly office visits during treatment weeks 8-20) or treatment arm (teledermatology visits during treatment weeks 8-20). The primary outcome is the change in total inflammatory lesion count. Secondary outcomes include changes in acne severity based on the Leeds scale, patient satisfaction, acne severity as perceived by the patient, cost and time-lost to patients and families, need for interim and unexpected urgent appointments, adverse medication effects. The investigators are hypothesizing that patients randomized to the treatment arm will have no statistically significant difference in total inflammatory lesion count or acne severity than the control arm. The investigators also hypothesize that adverse events will be equivalent in both groups and the treatment arm will report less cost associated with visits.
Read the detailed description
The role of telemedicine in dermatology is ever-expanding. Currently, teledermatology has been shown to be advantageous in disease processes that require frequent office follow-up visits such as psoriasis. In 2010, Watkins et al. demonstrated that teledermatology was effective in treating patients 16 years and older with moderate acne and demonstrated equivocal clinical outcomes as traditional office visits along with equivocal patient and provider satisfaction scores. More recently, Fruhauf et al. conducted a small study examining patients with severe acne on isotretinoin and found similar results in terms of safety and efficacy. Patients with severe acne on isotretinoin therapy currently are scheduled for monthly office visits in the dermatology clinic for at least six consecutive months during which time the severity of their acne is assessed by a dermatologist and dose adjustments are made accordingly. Patients are also required to get monthly laboratory studies immediately before, during, or after their visit, and this must be reviewed by the provider prior to prescription renewal according to iPledge guidelines. Given the fact that this medication is typically prescribed to teenagers or young adults, the high frequency of office visits put a significant burden on both patients and their families and results in unnecessary time missed from work or school.
- Conditions
- Acne Vulgaris
- Being tested
- Teledermatology visits
- Keywords
- Isotretinoin
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teledermatology visitsBehavioural
Patients in the treatment arm will be taught by study staff how to take the standardized photos of themselves at treatment week 4 (prior to initiation of teledermatology visits). For patients in the treatment arm, the teledermatology visits will be managed by the study staff. A monthly teledermatology visit will consist of sending facial and truncal (if affected) clinical images to a the study staff using Patient Gateway. Once this is completed, the patient and a member of the study staff will have a scheduled telephone appointment during which the provider will screen for any adverse events and will provide counseling as outlined in iPledge guidelines. The patient will also be asked to verbally complete a monthly survey assessing acne severity, quality of life, cost attributable to the appointment, time missed from school/work, satisfaction with treatment. All photographs will be uploaded in LMR/EPIC in the patient's medical record.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Patients in the treatment arm will have monthly office visits for weeks 0-4 and then have monthly teledermatology visits during weeks 8-20 with a final office visit at week 24. Standardized baseline photographs including 3 facial images (front, left, and right) as well as 2 truncal images of the chest and back (if affected) will be taken in the office at treatment week 0 and 24 for all patients. All patients will be required to take photos in front of a white wall to facilitate blinding. Receives: Behavioral: Teledermatology visits |
| Control arm | No intervention | Patients in the control arm will have the same series of photographs taken at each monthly visit. These patients will also be required to fill out a monthly survey assessing acne severity, quality of life, cost of attending appointment, time missed from school/work, satisfaction with treatment (only to be reviewed by study staff) and will be screened for adverse events by their provider. Every patient will be counseled about isotretinoin and contraception (if applicable) by their provider in order to adhere with iPledge requirements. All photographs will be uploaded into the patient's medical record. The physician will be required to document a progress note in the electronic medical record after each visit as per standard hospital protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total inflammatory lesion count
Lesion counting involves counting the number of inflammatory lesions on the face, chest, or back. This excludes comedonal acne.
Measured: Up to 24 weeks
Secondary outcomes (2)
Changes in acne severity
The Leeds scale will be used to assess patients' acne, which examines the extent of inflammation, range and size of inflamed lesions, and associated erythema. The Leeds technique is a counting system for detailed work in therapeutic trials. A scale of 0 (no acne) to 10 (most severe) is used for grading.
Measured: Up to 24 weeks
Patient satisfaction
This will be assessed by having the patient fill out a survey about how much time they missed and costs they may have incurred to go to the appointment. They will also be asked questions about how they feel their acne has affected their lives.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start1 Apr 2023
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Why it stopped: Study was planned prior to COVID-19; after pandemic teledermatology use became prevalent making the results of this study no longer necessary/relevant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Kroshinsky, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707236
- Sponsor's protocol ID
- 2018P001749
- Status last verified
- Apr 2023
- First submitted
- 28 Sep 2018
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Koller S, Hofmann-Wellenhof R, Hayn D, Weger W, Kastner P, Schreier G, Salmhofer W. Teledermatological monitoring of psoriasis patients on biologic therapy. Acta Derm Venereol. 2011 Oct;91(6):680-5. doi: 10.2340/00015555-1148.
PubMed 21879250Watson AJ, Bergman H, Williams CM, Kvedar JC. A randomized trial to evaluate the efficacy of online follow-up visits in the management of acne. Arch Dermatol. 2010 Apr;146(4):406-11. doi: 10.1001/archdermatol.2010.29.
PubMed 20404229Fruhauf J, Krock S, Quehenberger F, Kopera D, Fink-Puches R, Komericki P, Pucher S, Arzberger E, Hofmann-Wellenhof R. Mobile teledermatology helping patients control high-need acne: a randomized controlled trial. J Eur Acad Dermatol Venereol. 2015 May;29(5):919-24. doi: 10.1111/jdv.12723. Epub 2014 Sep 26.
PubMed 25258175Risk evaluation and mitigation strategy (REMS). iPLEDGE Program: Single Shared System for Isotretinoin. http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforP atientsandProviders/UCM234639.pdf . Accessed November 11, 2012.
Lucky AW, Barber BL, Girman CJ, Williams J, Ratterman J, Waldstreicher J. A multirater validation study to assess the reliability of acne lesion counting. J Am Acad Dermatol. 1996 Oct;35(4):559-65. doi: 10.1016/s0190-9622(96)90680-5.
PubMed 8859284Bergman H, Tsai KY, Seo SJ, Kvedar JC, Watson AJ. Remote assessment of acne: the use of acne grading tools to evaluate digital skin images. Telemed J E Health. 2009 Jun;15(5):426-30. doi: 10.1089/tmj.2008.0128.
PubMed 19548822Burke BM, Cunliffe WJ. The assessment of acne vulgaris--the Leeds technique. Br J Dermatol. 1984 Jul;111(1):83-92. doi: 10.1111/j.1365-2133.1984.tb04020.x.
PubMed 6234917Lee YH, Scharnitz TP, Muscat J, Chen A, Gupta-Elera G, Kirby JS. Laboratory Monitoring During Isotretinoin Therapy for Acne: A Systematic Review and Meta-analysis. JAMA Dermatol. 2016 Jan;152(1):35-44. doi: 10.1001/jamadermatol.2015.3091.
PubMed 26630323Suneja T, Smith ED, Chen GJ, Zipperstein KJ, Fleischer AB Jr, Feldman SR. Waiting times to see a dermatologist are perceived as too long by dermatologists: implications for the dermatology workforce. Arch Dermatol. 2001 Oct;137(10):1303-7. doi: 10.1001/archderm.137.10.1303.
PubMed 11594853Tsang MW, Resneck JS Jr. Even patients with changing moles face long dermatology appointment wait-times: a study of simulated patient calls to dermatologists. J Am Acad Dermatol. 2006 Jul;55(1):54-8. doi: 10.1016/j.jaad.2006.04.001. Epub 2006 May 6.
PubMed 16781292
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Teledermatology in the Treatment of Patients With Severe Acne on Isotretinoin: A Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT03707236
- Acronym / sponsor ID
- 2018P001749
- Conditions
- Acne Vulgaris
- Keywords
- Isotretinoin
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was planned prior to COVID-19; after pandemic teledermatology use became prevalent making the results of this study no longer necessary/relevant
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 16 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-blinded randomized controlled non-inferiority trial designed to assess the efficacy and role of teledermatology visits in the treatment of patients with severe acne starting isotretinoin. Males and females 16 years or older will be randomized to either the control arm (monthly office visits during treatment weeks 8-20) or treatment arm (teledermatology visits during treatment weeks 8-20). The primary outcome is the change in total inflammatory lesion count. Secondary outcomes include changes in acne severity based on the Leeds scale, patient satisfaction, acne severity as perceived by the patient, cost and time-lost to patients and families, need for interim and unexpected urgent appointments, adverse medication effects. The investigators are hypothesizing that patients randomized to the treatment arm will have no statistically significant difference in total inflammatory lesion count or acne severity than the control arm. The investigators also hypothesize that adverse events will be equivalent in both groups and the treatment arm will report less cost associated with visits.
Detailed description
The role of telemedicine in dermatology is ever-expanding. Currently, teledermatology has been shown to be advantageous in disease processes that require frequent office follow-up visits such as psoriasis. In 2010, Watkins et al. demonstrated that teledermatology was effective in treating patients 16 years and older with moderate acne and demonstrated equivocal clinical outcomes as traditional office visits along with equivocal patient and provider satisfaction scores. More recently, Fruhauf et al. conducted a small study examining patients with severe acne on isotretinoin and found similar results in terms of safety and efficacy. Patients with severe acne on isotretinoin therapy currently are scheduled for monthly office visits in the dermatology clinic for at least six consecutive months during which time the severity of their acne is assessed by a dermatologist and dose adjustments are made accordingly. Patients are also required to get monthly laboratory studies immediately before, during, or after their visit, and this must be reviewed by the provider prior to prescription renewal according to iPledge guidelines. Given the fact that this medication is typically prescribed to teenagers or young adults, the high frequency of office visits put a significant burden on both patients and their families and results in unnecessary time missed from work or school.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Behavioral: Teledermatology visitsPatients in the treatment arm will have monthly office visits for weeks 0-4 and then have monthly teledermatology visits during weeks 8-20 with a final office visit at week 24. Standardized baseline photographs including 3 facial images (front, left, and right) as well as 2 truncal images of the chest and back (if affected) will be taken in the office at treatment week 0 and 24 for all patients. All patients will be required to take photos in front of a white wall to facilitate blinding. |
| Control arm | No intervention | –Patients in the control arm will have the same series of photographs taken at each monthly visit. These patients will also be required to fill out a monthly survey assessing acne severity, quality of life, cost of attending appointment, time missed from school/work, satisfaction with treatment (only to be reviewed by study staff) and will be screened for adverse events by their provider. Every patient will be counseled about isotretinoin and contraception (if applicable) by their provider in order to adhere with iPledge requirements. All photographs will be uploaded into the patient's medical record. The physician will be required to document a progress note in the electronic medical record after each visit as per standard hospital protocol. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients must have a diagnosis of severe acne by a dermatologist with a plan of initiating treatment with isotretinoin
- Patients must first be enrolled in iPledge prior to eligibility
Key exclusion criteria (4 listed)
- Patients who have baseline hepatic dysfunction or hypertriglyceridemia
- Patients with a history of depression, suicide attempts or suicidal ideation
- Patients without access to internet or a camera (including portable camera and/or smart phone) at home
- Patients who are pregnant - absolute contraindication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teledermatology visitsPatients in the treatment arm will be taught by study staff how to take the standardized photos of themselves at treatment week 4 (prior to initiation of teledermatology visits). For patients in the treatment arm, the teledermatology visits will be managed by the study staff. A monthly teledermatology visit will consist of sending facial and truncal (if affected) clinical images to a the study staff using Patient Gateway. Once this is completed, the patient and a member of the study staff will have a scheduled telephone appointment during which the provider will screen for any adverse events and will provide counseling as outlined in iPledge guidelines. The patient will also be asked to verbally complete a monthly survey assessing acne severity, quality of life, cost attributable to the appointment, time missed from school/work, satisfaction with treatment. All photographs will be uploaded in LMR/EPIC in the patient's medical record. | Behavioural | Treatment arm |
Primary outcome
Change in total inflammatory lesion count
Time frame: Up to 24 weeks
Lesion counting involves counting the number of inflammatory lesions on the face, chest, or back. This excludes comedonal acne.
2 secondary outcomes
Changes in acne severity
Time frame: Up to 24 weeks
Patient satisfaction
Time frame: Up to 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Background: PubMed 21879250Koller S, Hofmann-Wellenhof R, Hayn D, Weger W, Kastner P, Schreier G, Salmhofer W. Teledermatological monitoring of psoriasis patients on biologic therapy. Acta Derm Venereol. 2011 Oct;91(6):680-5. doi: 10.2340/00015555-1148.
- Background: PubMed 20404229Watson AJ, Bergman H, Williams CM, Kvedar JC. A randomized trial to evaluate the efficacy of online follow-up visits in the management of acne. Arch Dermatol. 2010 Apr;146(4):406-11. doi: 10.1001/archdermatol.2010.29.
- Background: PubMed 25258175Fruhauf J, Krock S, Quehenberger F, Kopera D, Fink-Puches R, Komericki P, Pucher S, Arzberger E, Hofmann-Wellenhof R. Mobile teledermatology helping patients control high-need acne: a randomized controlled trial. J Eur Acad Dermatol Venereol. 2015 May;29(5):919-24. doi: 10.1111/jdv.12723. Epub 2014 Sep 26.
- BackgroundRisk evaluation and mitigation strategy (REMS). iPLEDGE Program: Single Shared System for Isotretinoin. http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforP atientsandProviders/UCM234639.pdf . Accessed November 11, 2012.
- Background: PubMed 8859284Lucky AW, Barber BL, Girman CJ, Williams J, Ratterman J, Waldstreicher J. A multirater validation study to assess the reliability of acne lesion counting. J Am Acad Dermatol. 1996 Oct;35(4):559-65. doi: 10.1016/s0190-9622(96)90680-5.
- Background: PubMed 19548822Bergman H, Tsai KY, Seo SJ, Kvedar JC, Watson AJ. Remote assessment of acne: the use of acne grading tools to evaluate digital skin images. Telemed J E Health. 2009 Jun;15(5):426-30. doi: 10.1089/tmj.2008.0128.
- Background: PubMed 6234917Burke BM, Cunliffe WJ. The assessment of acne vulgaris--the Leeds technique. Br J Dermatol. 1984 Jul;111(1):83-92. doi: 10.1111/j.1365-2133.1984.tb04020.x.
- Background: PubMed 26630323Lee YH, Scharnitz TP, Muscat J, Chen A, Gupta-Elera G, Kirby JS. Laboratory Monitoring During Isotretinoin Therapy for Acne: A Systematic Review and Meta-analysis. JAMA Dermatol. 2016 Jan;152(1):35-44. doi: 10.1001/jamadermatol.2015.3091.
- Background: PubMed 11594853Suneja T, Smith ED, Chen GJ, Zipperstein KJ, Fleischer AB Jr, Feldman SR. Waiting times to see a dermatologist are perceived as too long by dermatologists: implications for the dermatology workforce. Arch Dermatol. 2001 Oct;137(10):1303-7. doi: 10.1001/archderm.137.10.1303.
- Background: PubMed 16781292Tsang MW, Resneck JS Jr. Even patients with changing moles face long dermatology appointment wait-times: a study of simulated patient calls to dermatologists. J Am Acad Dermatol. 2006 Jul;55(1):54-8. doi: 10.1016/j.jaad.2006.04.001. Epub 2006 May 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Teledermatology visits in people with Acne Vulgaris, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total inflammatory lesion count (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03707236, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.